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Hindsight 20/20: Raymond Cohen

Hindsight 20/20 is a new Q&A feature where medtech industry veterans share their long experience taking diverse businesses – be they start-ups or publicly-listed entities – from strength to strength and navigating through times of crises. This first instalment shines the spotlight on Raymond Cohen, who is currently CEO of venture-backed sacral neuromodulation company Axonics Modulation Technologies, Inc. The advice he gives includes not rushing into clinical studies too soon, try to go big with the fundraising and be very cautious when tackling a complex market like the US, among other things.

Business Strategies Hindsight 2020 Medical Device

MDUFA IV (And More) Is Law: Trump Signs A Health-Care Bill

President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.

Policy Legislation United States

India Strikes Pricing Blow To Knees After Stent Cuts

Six months after imposing stiff price controls on cardiac stents, India’s government slashed costs of knee implants by nearly 70%, saying the action was necessary to end “unethical profiteering.”

Orthopedics India Market Access

Device Week – The Summer Of M&As, Aug. 21, 2017

In this week's Device Week podcast, we look at recent mergers and acquisitions. While the year started out slow, July was the busiest month for medtech M&A deals. At this rate the industry is set to break last year's deal count. We go in-depth into some of the major deals, and more.

Device Week M & A Medical Device
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Policy & Regulation Explore this Topic

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China's Latest Cybersecurity Proposal Could Heighten Scrutiny On Device, Drug Industries

Medtech and biopharma are among key information infrastructure industries likely subject to additional security and reporting obligations under draft legislation, adding costs and even potentially causing business disruptions, legal experts say.

China Cybersecurity Digital Health

Expanding The Medtech Toolbox: US FDA's 'Medical Device Development Tools' Program Rolls Out

Three years in the making, FDA has released a final guidance for medical device development tools that would allow developers to qualify their MDDTs and give medical device manufactures access to new tools that could help them prove safety and effectiveness of their products sooner.

Regulation Clinical Trials Research and Development Strategies

Cook Removes Indication, Pulls Sizes From Market Following Graft Recall

Cook Medical is pulling certain sizes of its Zenith Alpha thoracic endovascular graft from the market due to reports blood clots and occlusions may form inside the graft when it’s used to treat blunt traumatic aortic injury.

Medical Device Recalls

Dutch Law Banning Improper Inducements By Medtech To Carry Maximum €900,000 Fine

Medtech firms in the Netherlands will be subject to fines twice as high as that for pharma under a coming rule to ban improper inducements to healthcare professionals.

Europe Netherlands

PMA Supplement Studies Weak, Study Finds, As Past FDA Chief Califf Calls For More Rigor

The quality of studies used to support panel-track PMA supplement approvals need upgrading, as fewer than half were randomized, blinded or controlled and many relied on surrogate endpoints, says a study published in JAMA. In an accompanying editorial, former FDA commissioner Robert Califf, says it "raises concerns" that the US regulatory system has gotten "too permissive."

Clinical Trials Regulation

Patrick Conway Departs CMS As It Diverges From His Vision

Conway, a champion of the US agency's move into value-based care, will take the helm at Blue Cross/Blue Shield of North Carolina.

Policy Medical Device

Could CMS Changes To Bundled Pay Models Stifle Medtechs' Value-Based Pay Plans?

The US Center for Medicare and Medicaid Services proposed downsizing its CJR joint replacement value-based payment model and outright canceling its cardiac procedure bundled payment model. Will the move discourage companies like Zimmer Biomet, Johnson & Johnson, and Medtronic, which have already invested in programs based on the value-based models?

Reimbursement Market Access

Zimmer Faces HHS Inspector General Subpoena

The orthopedics manufacturer announced in a recent filing that the US Health and Human Services watchdog has asked for a range of records related to health-care consulting arrangements.

Medical Device Orthopedics

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Quality Replay: FDA Urges Firms To Close Loop On CAPAs, Create Filters To Weed Out Poor Quality Data

From our digital archives: Applying a closed-loop approach to corrective and preventive action activities is one of the best ways to ensure device quality and gather useful data, US FDA says. Manufacturers often fail to ensure that they complete the CAPA loop, leading to corrective and preventive actions that might be open for years, or product fixes that don’t work and complicate matters further by presenting the firms with a whole new set of challenges.

Quality Control Compliance

Quality Replay: Device History Record ‘Oversights’ A Clear Path To Quality Troubles, FDA Says

From our digital archives: Manufacturers are overlooking various key elements that should be included in device history records, including up-to-date labels, dates of product manufacture and missing signatures on documents, US FDA says. Because DHRs touch virtually every part of a firm’s quality system, a flawed DHR can prompt agency investigators to dig deeper during inspections. Experts from device firms Baxter and Thoratec weigh in.

Quality Control Compliance

Q2 Recalls Snapshot: Dramatic Increase In Class I Actions; Overall Recalls Dip Slightly

The number of high-risk class I recalls ballooned 88% in the second quarter of 2017. Overall, recalls fell 3%. Check out our Q2 recalls infographic.

Recalls Quality Control

Commercial Explore this Topic

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Voyage Into Point-Of-Care Testing Gets Deeper

Diagnostic testing is increasingly moving from centralized laboratories into pharmacies, physicians' offices, hospitals and directly to consumers as part of the transition to value-based care with its focus on providing quality care at a lower cost. Point-of-care testing (POCT) – and what it means for the future of health-care delivery, health-care providers and creators of innovative technologies joining forces to satisfy consumers' growing appetite for convenient and rapid testing – took centerstage at the recent AACC Annual Meeting in San Diego. This feature takes a closer look at the increasing migration of POCT into the retail arena, specifically pharmacies, to support primary-care providers, along with its challenges. It also highlights emerging trends and technologies, including presentations of the "Star Trek-like" innovations from the Qualcomm Tricorder XPrize competition winners that are bound to disrupt the landscape of direct-to-consumer testing. We also provide expert opinions of the pros and cons of bringing POC services closer to consumers.

In Vitro Diagnostics Diagnostics Market Intelligence

Latest From Commercial

Novacyt Full Of Eastern Promise, Following Strong H1 Sales

Cervical cancer screening firm Novacyt is aiming to broaden its market penetration in Asia-Pacific by identifying strategic acquisitions. The Anglo-French firm posted strong sales growth of 40% for the first six months of 2017, with APAC representing the group's fastest growing region.

Cancer In Vitro Diagnostics

UK Viewpoint: AHSNs, AAR And Accelerators – Market Access & Innovation Update

Dr Charlie Davie, managing director of UCLPartners, a London-based Academic Health Science Partnership and one of the 15 UK Academic Health Science Networks, updates Medtech Insight on key changes in NHS market access policy this summer.

United Kingdom Market Access

Could CMS Changes To Bundled Pay Models Stifle Medtechs' Value-Based Pay Plans?

The US Center for Medicare and Medicaid Services proposed downsizing its CJR joint replacement value-based payment model and outright canceling its cardiac procedure bundled payment model. Will the move discourage companies like Zimmer Biomet, Johnson & Johnson, and Medtronic, which have already invested in programs based on the value-based models?

Reimbursement Market Access

President Trump Disbands Business Advisory Councils

J&J and GE were among firms represented on the Trump administration's manufacturing council, one of two business advisory groups that were dissolved on Aug. 16 after a growing number of executives walked away from the endeavors in the wake of Trump's remarks regarding white nationalist demonstrations in Virginia.

Commercial United States

Gastric Balloon-Makers Respond To US FDA Warning

Apollo Endosurgery and Reshape Medical are both defending their products’ safety in the wake of a US FDA letter warning of five deaths tied to the companies' intragastric balloon devices.

Medical Device Gastroenterology

Pelvic Mesh Cases Continue As Endo Moves To Settle

Endo International announced plans this week to pay $775m to settle 22,000 US claims. Meanwhile, J&J is launching its sixth mesh lawsuit in Philadelphia and questioning jurisdiction.

Legal Issues Medical Device

Clinical R&D Explore this Topic

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US Approvals Analysis: Drug-Coated Balloon, Valve Tech Are July Highlights

July was a relatively light month for novel-device approvals by US FDA, but year-to-date volumes remain strong. Spotlighted devices include approval of a new drug-coated balloon and heart valve devices. Here's a roundup from Medtech Insight's Approval Tracker.

Approvals Innovation United States

Latest From Research & Development

Start-Up Spotlight: LimFlow, Endovascular Treatment For End-Stage Critical Limb Ischemia

French start-up LimFlow is developing a percutaneous deep vein arterialization system, designed for installing a stent-graft that shunts blood from a diseased tibial artery into a tibial vein to revascularize the foot of a patient with severe peripheral artery disease.

Diabetic Care Wound Management

OUS Approvals: Cardiovascular Devices Lead Modest List In July

July 2017 brought 26 approvals from outside the United States, including 14 CE marks in Europe and 12 from five other territories. Almost half of the approvals were for cardiovascular devices; the rest came from eight other categories.

Approvals Innovation

Abbott Launches Feasibility Trial Of Tricuspid Version Of MitraClip

The TRILUMINATE trial will evaluate safety and effectiveness of its Tricuspid Valve Repair System for treating symptomatic moderate-to-severe tricuspid regurgitation. The device is similar to Abbott's successful MitraClip catheter-based device for treating mitral regurgitation.

Clinical Trials Innovation

New Computer-Based Test Could Predict Breast Cancer Recurrence Risk

Scientists at the Institute of Cancer Research, London have developed a computer-based test that can identify women at high risk of relapsing from breast cancer within 10 years of diagnosis. The new image analysis tool looks at tissue samples taken as part of routine clinical practice and looks at the spatial distribution of immune cells in and around breast cancer, automatically.

Clinical Trials Cancer

Early-Stage UK NHS Innovations Get Sterling Boost From Medtech Accelerator

A new UK-based innovations award has selected its first batch of winners; the three projects that sprung from the National Health Service will share the £200,000 prize money to help progress their early-stage technologies. The Medtech Accelerator was launched at the end of 2016 as a joint venture between the NHS and regional business partners to provide funding for pioneering medical technologies developed by NHS staff.

Financing Innovation

Humabs Biomed Zika Assay Pinpoints Virus From Other Flavivirus Infections

A novel antibody-based Zika virus assay developed by Humabs Biomed, the NS1 Blockade-of-Binding (BOB) ELISA, can accurately distinguish Zika virus from other viruses, and differentiate it from other flavivirus infections within three hours, according to a recent article in the Proceedings of the National Academy of Sciences. Work to commercially develop the test is just beginning, so the company has not yet submitted it to FDA.

In Vitro Diagnostics United States
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